CurrentNeighborhood Health Plan of Rhode IslandPolicy 2426-A

tasimelteon (Hetlioz / Hetlioz LQ) coverage for Non-24 and Smith-Magenis Syndrome

Defines prior authorization, clinical criteria, required documentation, prescriber specialty, and authorization durations for tasimelteon (Hetlioz capsules and Hetlioz LQ oral suspension) for treatment of Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policytasimelteon (Hetlioz / Hetlioz LQ) coverage for Non-24 and Smith-Magenis Syndrome

Policy CodePolicy 2426-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization must be submitted with chart notes or test results showing required diagnostic confirmation (total blindness for Non-24 or confirmed Smith-Magenis Syndrome) for initial requests and documentation of benefit for continuation as specified.

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Covered Indications

1Prescriber specialty required

6 / 12 moAuthorization durations (initial / continuation)

Coverage Summary

Coverage stance: Covered with criteria. Tasimelteon (marketed as Hetlioz capsules and Hetlioz LQ oral suspension) is covered for its FDA‑approved indications when all approval criteria are met and there are no exclusions to the prescribed therapy.

Scope: Hetlioz is covered for Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) in adults and for nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) with age‑specific formulations: Hetlioz capsules for patients ≥16 years for SMS and Hetlioz LQ oral suspension for pediatric patients 3–15 years. All other uses are considered experimental/investigational and not medically necessary.

FDA-Approved Indications - Covered when ALL criteria met

Hetlioz is covered for FDA-approved indications when all approval criteria are met and there are no exclusions to the prescribed therapy.

Indication

Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
- The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas)
- The member is not able to perceive light in either eye
- The member is experiencing difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness
Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)
- Confirmed clinical diagnosis of Smith-Magenis Syndrome
- History of sleep disturbances

Initial Therapy Criteria

Documentation required to initiate prior authorization

Submission of the following is necessary to initiate prior authorization review.

Initial requests must include one of

Chart notes or test results showing total blindness in both eyes for Non-24-Hour Sleep-Wake Disorder (Non-24)
Chart notes or test results confirming Smith-Magenis Syndrome

Prior Authorization

Prior authorization required with documentation

Prior authorization must be submitted with chart notes or test results showing required diagnostic confirmation for initial requests and documentation of benefit for continuation as specified. Initial requests must include chart notes or test results confirming either total blindness in both eyes for Non-24 or a confirmed diagnosis of Smith-Magenis Syndrome.

Initial requests: chart notes or test results showing total blindness in both eyes for Non-24 OR chart notes/test results confirming Smith-Magenis Syndrome

Continuation Therapy Criteria

Documentation required to initiate prior authorization

Submission of the following is necessary to initiate prior authorization review.

Continuation requests must include one of the following pairings

For Non-24 continuation
- Chart notes or test results confirming total blindness in both eyes
- An increased total nighttime sleep and/or decreased daytime nap duration
For SMS continuation
- Chart notes or test results confirming Smith-Magenis Syndrome
- Improvement in quality of sleep such as improvement in sleep efficiency, sleep onset and final sleep offset, or waking after sleep onset

Documentation Required

Continuation documentation requirements

For continuation requests provide documentation as follows: For Non-24, include chart notes or test results confirming total blindness in both eyes AND evidence of increased total nighttime sleep and/or decreased daytime nap duration. For SMS, include chart notes or test results confirming Smith-Magenis Syndrome AND evidence of improvement in sleep quality (for example improved sleep efficiency, sleep onset and final sleep offset, or reduced waking after sleep onset).

Non-24 continuation: confirmation of total blindness in both eyes PLUS increased total nighttime sleep and/or decreased daytime naps
SMS continuation: confirmation of Smith-Magenis Syndrome PLUS improvement in sleep quality (e.g., sleep efficiency, sleep onset/offset, reduced wake after sleep onset)

Prescriber Specialty & Operational Requirements

Prescriber specialty requirement

Prescriber specialty requirement: Medication must be prescribed by or in consultation with a sleep specialist (e.g., neurologist experienced with sleep disorders, physician certified in sleep medicine) or psychiatrist

Documentation Required

Prescriber specialty documentation

Medication must be prescribed by or in consultation with a sleep specialist or a psychiatrist. If the prescriber is not a sleep specialist or psychiatrist, include documentation of consultation with an appropriate specialist (for example a neurologist experienced with sleep disorders or a physician certified in sleep medicine).

Prescriber must be a sleep specialist (e.g., neurologist experienced with sleep disorders, physician certified in sleep medicine) or psychiatrist, or include consultation documentation

Authorization Duration & Renewal

Prior Authorization

Authorization duration and renewal criteria

Initial authorizations may be granted for 6 months when all initial criteria for the indication are met (Non-24: total blindness, inability to perceive light, and sleep disturbance symptoms; SMS: confirmed diagnosis and history of sleep disturbances). Renewals/continuation authorizations may be granted for 12 months when documentation demonstrates benefit — for Non-24 this includes confirmation of total blindness and increased nighttime sleep and/or decreased daytime naps; for SMS this includes improvement in quality of sleep since starting therapy.

Initial authorization: up to 6 months for Non-24 or SMS when initial criteria are met
Renewal/continuation: up to 12 months when documentation shows clinical benefit (Non-24: increased nighttime sleep and/or decreased naps; SMS: improved sleep quality)

Clinical Evidence & References

References: Hetlioz [package insert]. Vanda Pharmaceuticals, January 2023; Tasimelteon [package insert]. Amneal Pharmaceuticals, January 2023; Auger RR et al., AASM Clinical Practice Guideline for intrinsic circadian rhythm sleep‑wake disorders, J Clin Sleep Med. 2015 Oct;11(10):1199‑1236.

Definitions & Background

Background: Tasimelteon (Hetlioz / Hetlioz LQ) is indicated for treatment of Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) in adults and for nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS). For SMS, Hetlioz capsules are indicated for patients 16 years of age and older, and Hetlioz LQ oral suspension is indicated for pediatric patients 3 to 15 years of age. Coverage is limited to these FDA‑approved indications; all other indications are considered experimental/investigational and not medically necessary.

Definition: Total blindness — diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas) and inability to perceive light in either eye, as required for Non‑24 coverage.